(137 days)
Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.
Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress, Threshold V2, and Palisade Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation System 57 (v2.1.0).
The provided text is a 510(k) Summary for the Spineology Navigation Instruments. While it describes the device, its intended use, and indicates that design verification testing was conducted, it does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria.
Here's an analysis of the information available and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing: The document states that "Design verification testing, including mating, registration, and accuracy, was conducted to ensure that Spineology Navigation Instruments are safe and effective for their intended use..." However, it does not list the specific acceptance criteria for "mating," "registration," or "accuracy." It also does not report the performance results (e.g., specific accuracy metrics, successful mating rates, or registration success rates) for the Spineology Navigation Instruments.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing: The document mentions "testing" but does not specify any sample sizes for the test sets used for mating, registration, or accuracy testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective/prospective). This type of device typically uses in-vitro or bench testing, not patient data in the same way an AI/software device would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable/Missing: For a stereotaxic instrument, "ground truth" is typically established through precise engineering measurements and metrology, not expert review of images or clinical outcomes in the same way an AI diagnostic device would. If the "accuracy testing" involved human assessment of alignment, the number and qualifications of those individuals are not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable/Missing: Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for establishing ground truth. For this type of device, which involves mechanical and software-based accuracy, "adjudication" in this sense is not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is a physical navigation instrument intended for use with a pre-existing medical device (Medtronic StealthStation® System), not an AI algorithm designed to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical instrument. While the StealthStation® System has an algorithm component, the Spineology Instruments themselves are not standalone algorithms. The testing here focuses on the instruments' compatibility and physical performance when used with the StealthStation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated/Implied by Device Type: For "accuracy testing" of navigation instruments, the ground truth would typically be established through highly precise mechanical measurements against known reference points, using CMMs (Coordinate Measuring Machines) or similar metrology equipment, rather than clinical ground truth like pathology or outcomes data. The document does not explicitly state the method for establishing this ground truth.
8. The sample size for the training set
- Not Applicable: This is a medical device, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: As above, this is not an AI/ML device requiring a training set.
Summary of what is present in the document regarding the study:
- Study Description: Design verification testing was performed, including "mating, registration, and accuracy."
- Purpose of Study: To ensure the instruments are safe and effective, functional, compatible with the Medtronic StealthStation®, and substantially equivalent to the predicate device.
- Comparison: Accuracy testing included a "side-by-side comparison of Spineology Navigation Instruments to the predicate device."
In conclusion, while the document confirms that testing was performed, it lacks the detailed information requested regarding specific acceptance criteria, performance results, sample sizes, and detailed methodology for establishing ground truth, which are typically found in more comprehensive study reports or test protocols. This 510(k) Summary focuses on demonstrating substantial equivalence primarily through design and technological characteristics and high-level summaries of testing, rather than an in-depth clinical or performance study report.
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January 5, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Spineology Inc. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street N.. Suite 600 Scandia, Minnesota 55128
Re: K172518
Trade/Device Name: Spineology Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 5, 2017 Received: December 6, 2017
Dear Jacqueline Hauge:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Spineology Navigation Instruments
Indications for Use (Describe)
Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the word "Spineology" in bold, black font. To the right of the word is a graphic of a cluster of purple dots. The dots are arranged in a circular pattern, with one large dot in the center and several smaller dots surrounding it.
510(k) Summary
| Date Prepared: | December 5, 2017 |
|---|---|
| Submitter: | Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128 |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Jacqueline A. HaugeRegulatory Affairs ManagerPhone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com |
Device Name and Classification
| Trade Name: | Spineology Navigation Instruments |
|---|---|
| Common Name: | Orthopedic Stereotaxic instrument |
| Classification Name: | Stereotaxic Instrument |
| Product Codes: | OLO |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 882.4560 |
| Panel: | Orthopedic |
Predicate Devices
| Primary: | K170679 | Medtronic Navigated Reusable Instruments for Use with StealthStation®and IPC® Powerease Systems (Medtronic Sofamor Danek) |
|---|---|---|
| Additional: | K153203 | Navigation Instruments (Globus Medical) |
1. Purpose
The purpose of this Premarket Notification is to obtain initial FDA clearance for Spineology Navigation Instruments which are intended for use with Spineology's Fortress, Threshold, Threshold V2, and Palisade Pedicular Fixation Systems and the Medtronic StealthStation® System.
2. Device Description
Spineology Navigation Instruments A.
Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress, Threshold V2, and Palisade Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation System 57 (v2.1.0).
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510(k) Summary
Image /page/4/Picture/1 description: The image shows the word "Spineology" in a bold, sans-serif font. The word is black, and the "o" in "Spineology" is slightly larger than the other letters. To the right of the word is a cluster of purple dots arranged in a circular pattern. The dots are of varying sizes, with the largest dot in the center and the smaller dots surrounding it.
B. Spineology Pedicular Fixation Systems
Spineology Fortress, Threshold V2, and Palisade Pedicular Fixation Systems consist of screws, curved and straight rods, and Connector devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating. These systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
3. Indications for Use
Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.
4. Technological Characteristics
When compared to the predicate devices, Spineology Navigation Instruments have the same intended use and similar technological characteristics, including:
- Design
- Materials of Construction
- Fundamental Scientific Technology
- Principle of Operation
- Function/Performance ●
ഗ് Non-Clinical Testing
Design verification testing, including mating, registration, and accuracy, was conducted to ensure that Spineology Navigation Instruments are safe and effective for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation®, and to demonstrate substantial equivalence to the predicate device.
- . Instrument mating testing evaluated the connection between the NavLock™ Tracker and Spineology Navigation Instruments.
- Registration testing was performed to ensure that Spineology Navigation Instruments can be registered to the StealthStation® System.
- Accuracy testing included a side-by-side comparison of Spineology Navigation Instruments to the predicate device.
6. Conclusion
Based on the intended use, technological characteristics, and comparison to the predicate devices, Spineology Navigation Instruments have been shown to be substantially equivalent to the legally marketed predicate devices.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).